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Prop 65 Hazard Awareness & EPA/CARB Formaldehyde Regulations: A Look at Compliance and What’s Next Benchmark International, LLC

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Page 1: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Prop 65 Hazard Awareness & EPA/CARB Formaldehyde Regulations: A Look at Compliance and What’s NextBenchmark International, LLC

Page 2: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

NOTICE:

The content of this presentation is for general information purposes only. This document is neither intended, nor should it be construed, as legal advice. Neither Benchmark International, LLC nor any of its related companies, subsidiaries, affiliates, managers, or employees make any warranty, express or implied, regarding the information defined or referenced herein. In the event of an inadvertent content error or inconsistency, the requirements specified in the applicable statute, regulation, or standard shall dictate.

Organizations or individuals seeking legal advice regarding compliance with any statute, regulation, or standard should consult with a qualified legal professional with expertise in the specific area(s) of interest. To the extent this information references best practices that may enhance conformance to applicable statutes, regulations or standards, but that are not specifically required by such statute, regulation, or standard; this information cannot and does not create additional legal obligations.

The copyright for this presentation is the property of Benchmark International, LLC. This presentation is supplied on the expressed condition that the content must not be used for purposes other than that for which it has been supplied. This document may not be reproduced, republished, distributed, transmitted, broadcast, or otherwise exploited in any manner, in whole or in part, without the prior written permission of Benchmark International, LLC. All rights reserved.

Copyright Benchmark International, LLC. All Rights Reserved.2

Page 3: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.3

AGENDA:

1. About Benchmark International, LLC

2. EPA and CARB Review:

a. EPA Implementation Status – A Recap

b. EPA vs. CARB – How do they compare?

c. EPA/CARB Compliance Recommendations for Fabricators, Importers, Distributors, and Retailers

d. Formaldehyde Regulatory Affairs

3. California Proposition 65 Overview

Page 4: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.4

WHO IS BENCHMARK?

• ISO/IEC 17065 Product Certification (IAS PCA-109)

• ISO/IEC 17025 Laboratory Test (IAS TL-280)

• ISO/IEC 17020 Third-Party Inspection (IAS AA-660)

• Japanese Agricultural Standards (JAS)

• EPA- and CARB-approved Third Party Certifier (TPC-2)

• NALFA-Approved Test Laboratory

• Other Services:

✓ Compliance Program Consulting (Lacey Act, CA Prop 65, etc.)

✓ Supply Chain Audit/Inspection

✓ Product QA/QC Inspection & Testing

✓ Design & Engineering

Page 5: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.5

TIME

• Final EPA TSCA Title VI (40 CFR 770) rule published in U.S. Federal Register

• Rule effective date delayed by Executive Order to March 21, 2017

MARCH 20, 2017DECEMBER 12, 2016 AUGUST 25, 2017

• Direct Final Rule takes effect to permit early labeling of TSCA Title VI-certified panels and compliant finished goods

SEPTEMBER 25, 2017

• Final Rule published to extend manufacturer/importer compliance deadline to December 12, 2018; other compliance deadlines also extended

OCTOBER 31, 2017

• Sierra Club files lawsuit challenging EPA’s authority to extend the compliance deadlines

MARCH 13, 2018

• U.S. District Court for Northern District of California issues order to resolve Sierra Club litigation; final compliance deadlines established by joint stipulation agreement

JANUARY 26, 2017

• Rule effective date delayed again to May 22, 2017

MAY 22, 2017

• EPA TSCA Title VI (40 CFR 770) takes effect

• Accreditation Bodies (AB) can apply for EPA recognition

• CARB TPC’s can apply for EPA recognition (reciprocity)

JUNE 1, 2018

• Composite wood panels and finished goods must be certified and labeled as conforming to either TSCA Title VI OR CARB Phase 2 by a TPC that is approved by CARB and recognized by EPA

MARCH 22, 2019

• Products must be certified and labeled as conforming to TSCA Title VI; CARB Phase 2 no longer accepted outside California

• Import certification rule takes effect

• Transition period for CARB TPC’s ends; TPC's must comply with additional accreditation requirements to remain EPA-recognized

MARCH 22, 2024

• Laminated Product Producers must be TPC-certified unless exempt on the basis of the use of NAF or phenol resins

TSCA TITLE VI TIMELINE – HOW DID WE GET HERE?

Copyright Benchmark Interna3onal, LLC. All Rights Reserved.5

TIME

• Final EPA TSCA Title VI (40 CFR 770) rule published in U.S. Federal Register

• Rule effective date delayed by Executive Order to March 21, 2017

MARCH 20, 2017DECEMBER 12, 2016 AUGUST 25, 2017

• Direct Final Rule takes effect to permit early labeling of TSCA Title VI-cer3fied panels and compliant finished goods

SEPTEMBER 25, 2017

• Final Rule published to extend manufacturer/importer compliance deadline to December 12, 2018; other compliance deadlines also extended

OCTOBER 31, 2017

• Sierra Club files lawsuit challenging EPA’s authority to extend the compliance deadlines

MARCH 13, 2018

• U.S. District Court for Northern District of California issues order to resolve Sierra Club litigation; final compliance deadlines established by joint stipulation agreement

JANUARY 26, 2017

• Rule effec3ve date delayed again to May 22, 2017

MAY 22, 2017

• EPA TSCA Title VI (40 CFR 770) takes effect

• Accredita3on Bodies (AB) can apply for EPA recogni3on

• CARB TPC’s can apply for EPA recogni3on (reciprocity)

JUNE 1, 2018

• Composite wood panels and finished goods must be certified and labeled as conforming to either TSCA Title VI OR CARB Phase 2 by a TPC that is approved by CARB and recognized by EPA

MARCH 22, 2019

• Products must be certified and labeled as conforming to TSCA Title VI; CARB Phase 2 no longer accepted outside California

• Import certification rule takes effect

• Transition period for CARB TPC’s ends; TPC's must comply with additional accreditation requirements to remain EPA-recognized

MARCH 22, 2024

• Laminated Product Producers must be TPC-cer3fied unless exempt on the basis of the use of NAF or phenol resins

TSCA TITLE VI TIMELINE – HOW DID WE GET HERE?

Page 6: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.6

RequirementManufacturer/ Panel Producer

Laminated Product Producer

(EPA DEFINITION) Fabricator Importer Distributor Retailer

Emission Standards: ✓ ✓ ✓ ✓ ✓ ✓

Written Quality System: ✓ ✓EPA by March 22, 2024

✕ ✕ ✕ ✕

Third Party Certification: (or Qualified Exemption)

✓EPA by June 1, 2018

✓EPA by March 22, 2024

✕ ✕ ✕ ✕

Product Testing: ✓ ✓ ✕ ✕ ✕ ✕

Labeling: ✓EPA by June 1, 2018

✓EPA by March 22, 2024

✓EPA by June 1, 2018

‼️ ‼️ ‼️

Reasonable PrudentPrecautions:

‼️(for HWPW, MDF, or PB sourced for HWPW-CC

production)

✓(for HWPW, MDF, or PB

sourced to make laminated products)

✓ ✓ ✓ ✓

Import Declaration: (EPA Only)

‼️EPA by 3/22/2019

‼️EPA by 3/22/2019

‼️EPA by 3/22/2019

‼️EPA by 3/22/2019

‼️EPA by 3/22/2019

‼️EPA by 3/22/2019

Invoice/Bill of Lading: ✓ ✓ ✓ ✓ ✓ ✕

Record Keeping: ✓ ✓ ✓ ✓ ✓ ✓

EPA/CARB Facility Inspections: ✓ ✓ ✓ ✓ ✓ ✓

KEY:

✓REQUIRED; ‼️ IF APPLICABLE; ✕NOT REQUIRED/APPLICABLE

HOW DO EPA & CARB REQUIREMENTS APPLY?

Page 7: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.7

WHAT DATES DO I NEED TO REMEMBER?

• March 22, 2019:

➢ Regulated products must be certified and labeled as conforming to EPA TSCA Title VI (CARB Phase 2 no longer accepted outside California)

➢ Import certification rule takes effect

➢ CARB TPCs must comply with additional EPA accreditation requirements and re-apply to EPA for recognition to continue offering certification services

• March 22, 2024:

➢ Laminated Products Rule takes effect; laminated product producers must achieve third party certification unless exempt on the basis of the use of NAF or Phenol resins

Page 8: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.8

WHAT IS THE IMPORT CERTIFICATION RULE?

The import certification date is March 22, 2019

• Applies to importers of composite wood panels and component parts/finished goods per 40 CFR §770.30

• Leverages ACE system to accept electronic import certifications (TSCA Section 13 and 19 CFR 12.118-12.127)

• Flagged HTSUS Chapters 44, 70, 85, 87, 92, 94, 95 (use disclaim code if TSCA Title VI does not apply)

• Negative import certification is not permitted:

➢ implication to handling of noncomplying lots identified after the goods have shipped.

Page 9: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.9

WHAT ARE LAMINATED PRODUCTS?

CARB Definition:

• Finished good or component part in which a laminate or laminates are affixed to a HWPW, MDF, or PB platform.

• The HWPW, MDF, or PB platform must be CARB-certified.

• More broadly defined than EPA term

• Produced by a Fabricator

• Underlying HWPW, MDF, or PB component must conform to the applicable CARB P2 emission limit, but no emission standard applicable to the laminated product itself

Paper on MDF Melamine on HWPW, MDF, or PB

Wood veneer on HWPW, MDF, or PB

Bamboo veneer on HWPW, MDF, or PB

✅ ✅

✅ ✅

Page 10: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.10

WHAT ARE LAMINATED PRODUCTS?

EPA Definition:

• Component part/finished good in which a wood or bamboo veneer is adhered to an EPA-compliant HWPW, MDF, or PB core or platform

• Produced by a Laminated Product Producer

• Comply with Fabricator requirements until 2024

• TPC-certification by March 22, 2024

• Subset of hardwood plywood; ≤0.05ppm

• Exemption if using No-Added Formaldehyde (NAF) or phenol resins (additional record-keeping requirements apply)

Paper on MDF Melamine on HWPW, MDF, or PB

Wood veneer on HWPW, MDF, or PB

Bamboo veneer on HWPW, MDF, or PB

❌ ❌

✅ ✅

Page 11: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.11

COMPLIANCE FOR IMPORTERS, FABRICATORS, DISTRIBUTORS, & RETAILERS:

• Stakeholder outreach is needed to further promote understanding and facilitate compliance

• Basic “Must-Do’s” for Regulated Entities Importing to the USA

1. Comply with Emissions Standards

2. Meet Compliance Deadlines

3. Reasonable Prudent Precautions (Risk-Based)

4. Labeling (Requirements for Panels vs. Component Parts/Finished Goods)

5. Record-keeping and Transaction-Related Obligations

6. Import Certification

Page 12: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.12

COMPLIANCE FOR IMPORTERS, FABRICATORS, DISTRIBUTORS, & RETAILERS:Panel Producer

EPA Certification Process

HWPW

HWPW

HWPW

HWPW

MDF

MDF

Finished Goods

Fabricator using EPA-

certified CWP

Manufacture & Ship

Issue P.O.

U.S. Purchaser/ Importer

Issue P.O.

Fabricate & Ship

THIS PROCESS TAKES TIME - THINK ABOUT SUPPLY CHAIN IN LIGHT OF COMPLIANCE DEADLINES

Page 13: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.13

SOME EXAMPLES OF REASONABLE PRUDENT PRECAUTIONS:

• Written EPA/CARB compliance program policy/procedure

• Specify compliance requirements in writing; obtain written supplier acknowledgement

• Obtain TPC certificates (or NAF/ULEF exemption) – validate with TPC

• Request TPC quarterly audit report or verification letter – verify “good standing”

• Request copies of TPC quarterly test reports from manufacturer

• Request copies of QC test reports (or COA) from manufacturer for EACH lot of CWP

• Request TPC-calculated QCL and small scale test method correlation from manufacturer

• Request reports to demonstrate proper labeling prior to delivery

• Conduct risk-based site audits/inspections of Fabricators and Manufacturers

• Conduct periodic testing of incoming shipments using an accredited laboratory

Page 14: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

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EXAMPLES OF RECORDS REQUESTED DURING ENFORCEMENT PROCEEDINGS:

• Panel Producer name/contact information & date of production

• Supplier name/contact information & date of purchase (if different from panel producer)

• Supplier invoices/bills of lading for each incoming shipment

• Quantity/value of product manufactured, imported, and sold in the U.S.A./California

• Representative copies of labels used

• For finished goods, the names of the panel producers who manufactured composite wood panels used in the fabrication of finished goods

• The name and contact information of the TPC who certifies the panel producer

• Results of ANY emissions testing performed, if any

• Import certification records (on or after 3/22/2019)

• Records of all reasonable prudent precautions taken

Page 15: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

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CARB 93120 Amendment Process

2013 2014 2015-2017 2018-19?• CARB publishes

proposed draft changes to CARB 93120 regulations in Nov 2013

• Modifications intended, in part, to align CARB 93120 with proposed EPA regulations

• Public meeting and comment period completed Nov/Dec 2013

• CARB publishes updated draft amendments

• Issues draft proposal intended to address industry concerns regarding proposed EPA Fabricator laminated product requirements

• Public meeting and comment period completed Mar/Apr 2014

• CARB and EPA continue efforts to align regulations to the extent possible

• CARB states publicly they intend to wait until EPA regulations are published before finalizing draft amendments

• EPA publishes final TSCA Title VI regulation (40 CFR Part 770) in Dec 2016

• Timeline of amendment process remains unclear –mid/late 2019?

• Process will include a series of draft amendments and public workshops to review proposed changes

• Regulated stakeholders are highly encouraged to participate in public comment activities

Page 16: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

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Canada Formaldehyde Rule

Dec 2016 Early 2017 Late 2017-18 2019

• Private Members’ motion introduced to Canada House of Commons to adopt formaldehyde regulations similar to US EPA requirements

• Regulations to fall under Canadian Environmental Protection Act of 1999

• Mar 2017: Canada Depts. of Environment & Health issue notice of intent to develop formaldehyde emission regulations

• Apr 2017: Introductory webinars & voluntary data gathering questionnaire

• May 2017: House of Commons unanimously agrees to proceed with developing regulations

• July 2017: Health Canada publishes consultation document; outlines proposed regulatory approach

• Intend to model after existing CAN/CSA 0160-16 standard and CARB & EPA regulations

• Sep 2017: Public meeting conducted to review consultation document and seek stakeholder input

• Early/Mid 2019: Draft regulation targeted for publication in Canada Gazette, Part I [Public comment period 60-75 days)

• Fall 2019: Final regulation targeted for publication

Page 17: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.17

• Specific Questions Send to:

➢ Substance Management Information Line, citing “Formaldehyde Inquiry” [email protected]

• Web/E-Mail Updates:

➢ Chemical Substances:

https://www.canada.ca/en/health-canada/services/chemical-substances/other-chemical-substances-interest/formaldehyde.html#a3

➢ Latest News Listserv subscription: http://www.chemicalsubstanceschimiques.gc.ca/listserv/index-eng.php

CANADA FORMALDEHYDE RULE – HOW DO I RECEIVE UPDATES?

Page 18: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.18

• Visit websites of regulatory or standards development bodies for status updates

• Subscribe to listserv emails to obtain up-to-date notifications on the status of regulatory activities

CARB: https://www.arb.ca.gov/listserv/listserv_ind.php?listname=compwood

EPA: https://www.epa.gov/formaldehyde (subscribe to updates for individual docket folders as needed)

• Attend public meetings or participate in regulatory comment periods hosted by regulators/ standards developers

• Get involved with U.S. and Canadian standards development bodies such as ANSI, ASTM, & CSA

• Participate with relevant industry associations. Examples include but are not limited to:

➢ RILA – Retail Industry Leaders Association

➢ AHFA – American Home Furnishings Alliance

➢ IWPA – International Wood Products Association

➢ KCMA – Kitchen Cabinet Manufacturer’s Association

➢ NWFA – National Wood Flooring Association

HOW CAN I SUPPORT EPA/CARB REGULATORY AFFAIRS?

Page 19: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.19

WHAT IS PROPOSITION 65 (PROP 65)?

• California “Safe Drinking Water and Toxic Enforcement Act of 1986”

• Administered by CalEPA’s Office of Environmental Health Hazard Assessment (OEHHA)

• Prohibits businesses from:

1. discharging listed substances into drinking water sources (or onto land where substances can pass into drinking water sources)

2. knowingly exposing individuals to listed substances without providing a clear and reasonable warning

• Requires businesses to provide warnings for 970+ substances known to the State to cause cancer or birth defects/reproductive harm

Page 20: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

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WHAT IS THE PROP 65 LIST?

• A list of naturally occurring and synthetic substances that are known to the State to cause:

➢ Cancer

➢ Birth defects or other forms of reproductive harm

• Additives or ingredients in pesticides, household chemicals, food, drugs, dyes, or solvents

• Chemicals used in manufacturing and construction

• Byproducts of chemical processes

• List available at: https://oehha.ca.gov/proposition-65/proposition-65-list

Page 21: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

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WHY IS PROP 65 UNIQUE?

• Enforced almost exclusively through civil lawsuits and legal settlements brought by the private sector

Data Source: https://oag.ca.gov/prop65/annual-settlement-reports

Page 22: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

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WHY IS PROP 65 UNIQUE?

• On average, 72% of total annual enforcement settlement dollars levied in the last 5 years went to the lawyers

Data Source: https://oag.ca.gov/prop65/annual-settlement-reports

Page 23: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

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WHAT ARE THE LATEST DEVELOPMENTS WITH PROP 65?

• New Warning Regulations: Effective August 30, 2018

➢ Establishes voluntary methods of transmission and content warnings deemed compliant to Prop 65

➢ Does not address the question of whether a warning is required

➢ Safe Harbor Levels: Daily threshold of exposure above which a warning is required:

❖ Cancer Agents: No Significant Risk Levels (NSRL)

❖ Birth Defects/Reproductive Harm: Maximum Allowable Dose Levels (MADL)

➢ Safe Harbor levels published for 300+/970+ of the Prop 65 listed substances

➢ A product label does not necessarily cover you! Warnings must be appropriate to the distribution/sales method and provided before a consumer makes a purchase decision or is exposed.

Page 24: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Copyright Benchmark International, LLC. All Rights Reserved.24

WHERE DO I START WITH MY PROP 65 COMPLIANCE EFFORTS?

Does product contain a listed chemical?

Yes or NoNo warning needed

Conduct exposure assessment for each

listed chemical

Exposure exceeds

Safe Harbor?

Identify all means used to distribute/sell the

product in CA

Determine method of transmission applicable

to distribution/sales methods:

• Pre-purchase warnings (websites and catalogs)

• Product Labels• In-store signage• Written notice to

downstream entities

Establish applicable product warnings:

• Cancer• Reproductive Harm• Product-specific warnings

(e.g. wood dust, furniture)

Provide warnings

Yes

No

YesNo

Page 25: Prop 65 Hazard Awareness & EPA/CARB Formaldehyde

Thank You!

Chris BattinVP/General Manager, Certification & Laboratory ServicesPhone: +1 (541) 484-9212E-mail: [email protected]